Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • HIV/AIDS
  • Immunosuppression
  • Kaposi Sarcoma
Type
Interventional
Phase
Early Phase 1
Design
Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Standard 3+ 3 design during the initial safety cohort, then expansion cohortMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Infection with Kaposi sarcoma herpesvirus (KSHV, or human herpesvirus-8 (HHV-8)) causes Kaposi sarcoma (KS). These virally associated diseases occur more frequently in HIV-infected individuals, but can also be found in HIV-uninfected population. Evolution of immunosuppressive mechanisms presumably p...

Infection with Kaposi sarcoma herpesvirus (KSHV, or human herpesvirus-8 (HHV-8)) causes Kaposi sarcoma (KS). These virally associated diseases occur more frequently in HIV-infected individuals, but can also be found in HIV-uninfected population. Evolution of immunosuppressive mechanisms presumably plays a permissive role in the development, progression and recurrence of these virus-associated cancers and pre-cancers. Currently, available treatment options for these lesions are imperfect. The goal of this study is to determine whether intra-lesional injections of nivolumab can enhance specific T cell responses in vitro and enhance activity against these virus-associated lesions. Chronic viral infections generate "exhausted" CD8+ T cells with a diminished capacity to produce cytokines and to lyse infected cells. The PD-1 (program death-1)/PD-L1 (program death ligand-1) pathway implicated in the balance between immune eradication and immune escape. This study will evaluate the safety, tolerability, and potential benefits of injecting nivolumab into KS in HIV-infected and HIV-uninfected individuals every 2 weeks for total of 4 doses. The investigators believe this mode of treatment is feasible and tolerable by avoiding the systemic autoimmune adverse events caused by systemic injection of nivolumab.

Tracking Information

NCT #
NCT03316274
Collaborators
Bristol-Myers Squibb
Investigators
Principal Investigator: Chia-ching Wang, MD University of California, San Francisco